Artificial heart valve composite material and preparation method thereof

Abstract

The invention provides a preparation method of an artificial heart valve composite material, which comprises the following steps: preparing a modified fabric layer, preparing a polymer layer with bulges on the surface, and finally fully fusing the bulges of the modified fabric layer and the polymer layer, thereby obtaining the composite material with both the flexibility of a fabric and the smoothness of a polymer. According to the technical scheme, the bulges are introduced into the composite material, so that the polymer layer and the modified fabric layer can be combined more stably, the stability of the composite material is enhanced, an irregular pore structure can be formed in the composite material, and the phenomenon that the polymer layer is adhered to the modified fabric layer is avoided; the softness of the modified fabric layer is influenced, the softness of the fabric is kept to the maximum extent by the composite material, and the composite material is endowed with excellent opening and closing performance.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to an artificial heart valve composite material and a preparation method thereof. Background Art

[0002] An artificial heart valve is an artificial organ that can be implanted into the heart to replace the heart valve, enabling unidirectional blood flow and having the functions of a natural heart valve. When the heart valve lesion is severe and the valve function cannot be restored or improved by valve separation surgery or repair surgery, an artificial heart valve replacement surgery must be performed.

[0003] Currently, textile-based artificial hearts prepared by textile technology have broad application prospects in the fields of surgical valves, transcatheter valves, valved conduits, tissue engineering valves, etc. due to the high biocompatibility of the materials obtained. This is mainly because such methods can precisely control the composition, thickness, and structure of the stent material to adjust the geometric shape and biomechanical properties of the finally obtained material. The leaflet materials of existing textile-based artificial heart valves are generally pure fabrics composed of polymer fibers / yarns or composite materials formed with a fabric base. However, pure fabrics have problems such as leakage, easy structural deformation, and rough surfaces prone to thrombus formation; while composite materials obtained by combining fabrics with polymers can overcome the above problems to a certain extent.

[0004] In the prior art, in the technical solution with the application number 202111316032.9, the publication date of May 9, 2023, and the name of "A Polymer Valve, Valve Assembly and Its Preparation Method", a coating and a transition layer are formed successively on a matrix layer based on a fiber base. During the preparation process, active groups are formed in the base layer by means of surface treatment to utilize the chemical bonding between the active groups and the transition layer to connect the base layer and the transition layer together. In the above technical solution, the method of forming a coating and a transition layer on the matrix layer and using the chemical bonding between the base layer and the transition layer to combine the two can improve the bonding force between the various parts inside the material and make the material more stable. However, since the transition layer is directly formed on the base layer, it is not only difficult to regulate the surface structure of the obtained material but also unable to exert the advantages of the fabric as a valve.

[0005] In view of this, it is necessary to design an improved artificial heart valve composite material and a preparation method thereof to solve the above problems. Summary of the Invention

[0006] The purpose of the present invention is to provide an artificial heart valve composite material and a preparation method thereof. This technical solution prepares a modified fabric layer and then prepares a polymer layer with protrusions on the surface. By using the protrusions to combine the modified fabric layer and the polymer layer, a composite material with both the flexibility and smoothness of the fabric can be obtained.

[0007] To achieve the above-mentioned invention object, on the one hand, the present invention provides an artificial heart valve composite material, and the composite material includes:

[0008] A modified fabric layer, including a fabric and a first polymer layer located on both side surfaces of the fabric;

[0009] A second polymer layer, with a plurality of protrusions provided on one side surface of the second polymer layer, and the other side surface of the second polymer layer being smooth;

[0010] The second polymer layer is located on both sides of the modified fabric layer;

[0011] For each second polymer layer, the side surface with the protrusions is located on the surface of the first polymer layer, and an irregular pore structure is formed between the second polymer layer, two adjacent protrusions and the first polymer layer.

[0012] Preferably, the pore diameter of the pore structure is 50 - 300 μm, and the surface roughness of the composite material is 80 - 300 nm.

[0013] On the other hand, the present invention also provides a preparation method of the artificial heart valve composite material, including the following steps:

[0014] Immerse the fabric in a first polymer solution to form a first polymer layer on the surface of the fabric, and obtain a modified fabric layer;

[0015] Coat a second polymer solution on a smooth substrate, and obtain a second polymer layer after drying;

[0016] Perform surface treatment on the second polymer layer to form a plurality of protrusions on one side surface of the second polymer layer;

[0017] Respectively attach the side surfaces with the protrusions of the two second polymer layers to the surface of the first polymer layer. Under the action of pressure, combine the modified fabric layer with the second polymer layer, and an irregular pore structure is formed between the second polymer layer, two adjacent protrusions and the first polymer layer. After secondary drying, the artificial heart valve composite material is obtained.

[0018] Preferably, the mass concentration of the second polymer solution is 5 - 30 w / v%; the coating thickness of the second polymer solution is 100 - 1000 μm.

[0019] Preferably, the solute of the second polymer solution is one or more of polyurethane, polycarbonate-polyurethane copolymer, polysiloxane-polyurethane copolymer, and styrene / isobutylene copolymer; the solvent of the second polymer solution is one or more of N,N-dimethylformamide, N,N-dimethylacetamide, dimethyl sulfoxide, tetrahydrofuran, dioxane, chloroform, dichloromethane, hexafluoroisopropanol, and dioxolane.

[0020] Preferably, the thickness ratio of the second polymer layer to the modified fabric layer is 1:5 - 5:1.

[0021] Preferably, the magnitude of the pressure is 10 - 100 kPa.

[0022] Preferably, the protrusions are formed by intermittently coating a surface treatment liquid on the surface of the second polymer layer; the surface treatment liquid is one of an organic solvent or a second polymer solution.

[0023] Preferably, the protrusions are formed by locally melting the second polymer layer by means of heat, light, or radiation.

[0024] Preferably, the solute of the first polymer solution is one or more of polyurethane, polycarbonate-polyurethane copolymer, polysiloxane-polyurethane copolymer, and styrene / isobutylene copolymer; the solvent is one or more of N,N-dimethylformamide, N,N-dimethylacetamide, dimethyl sulfoxide, tetrahydrofuran, dioxane, chloroform, dichloromethane, hexafluoroisopropanol, and dioxolane.

[0025] The beneficial effects of the present invention are as follows:

[0026] 1. The preparation method of the artificial heart valve composite material provided by the present invention first prepares a modified fabric layer, then prepares a second polymer layer with protrusions on one surface and a smooth surface on the other surface, and finally makes the protrusions of the modified fabric layer and the second polymer layer fully fuse, thereby obtaining a composite material that simultaneously has the flexibility and smoothness of the fabric. Through the above technical solution, by introducing protrusions inside the composite material, it is not only beneficial for the second polymer layer and the modified fabric layer to be more firmly combined, enhancing the stability of the composite material, but also capable of forming an irregular pore structure in the composite material, avoiding affecting the softness of the modified fabric layer itself after attaching the second polymer layer to the modified fabric layer, ensuring that the composite material maximally retains the softness of the fabric itself, and endowing the composite material with excellent opening and closing properties.

[0027] 2. The preparation method of the artificial heart valve composite material provided by the present invention prepares a second polymer layer, and after surface treatment, under the action of pressure, the modified fabric layer and the second polymer layer are combined together, ensuring that the composite material has a smooth surface structure, which is beneficial for blood flow and avoids the occurrence of thrombosis.

[0028] 3. The preparation method of the artificial heart valve composite material provided by the present invention is obtained by treating a fabric with a polymer. The preparation method is simple and easy to control. By regulating conditions such as the type and concentration of the polymer solution during the preparation process, precise control of the properties of the composite material is achieved, which has high application value. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 It is a cross-sectional SEM image of the artificial heart valve composite material prepared in Example 1 of the present invention;

[0030] Figure 2 It is a planar SEM image of the artificial heart valve composite material prepared in Example 1 of the present invention;

[0031] Figure 3 It is a cross-sectional SEM image of the artificial heart valve composite material prepared in Comparative Example 1 of the present invention. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0032] In order to make the objectives, technical solutions, and advantages of the present invention clearer, the present invention will be described in detail below with reference to the accompanying drawings and specific embodiments.

[0033] Here, it should also be noted that in order to avoid obscuring the present invention due to unnecessary details, only the structures and / or processing steps closely related to the solution of the present invention are shown in the drawings, while other details less related to the present invention are omitted.

[0034] In addition, it should also be noted that the term "comprising", "including" or any other variant thereof is intended to cover non-exclusive inclusion, such that a process, method, article or device comprising a series of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such process, method, article or device.

[0035] Please refer to Figure 1 As shown, an artificial heart valve composite material provided by the present invention, the above composite material includes:

[0036] A modified fabric layer, including a fabric and a first polymer layer attached to both sides of the fabric;

[0037] Two second polymer layers and a modified fabric layer attached between the two second polymer layers. A number of protrusions are formed on one side of the second polymer layer close to the modified fabric layer, and the other side surface is smooth. An irregular pore structure is formed between the polymer layer and the modified fabric layer, and the pore size of the pore structure is 50 - 300 μm. The surface roughness of the composite material is 80 - 300 nm. It should be noted that the surface roughness of the composite material here refers to the surface roughness of the side of the second polymer layer far from the modified fabric layer.

[0038] Specifically, the preparation method of the above artificial heart valve composite material includes the following steps:

[0039] Immerse the fabric in the first polymer solution to form a first polymer layer on the fabric surface, and obtain the modified fabric layer;

[0040] Coat the second polymer solution on the substrate, and obtain the second polymer layer after drying; then, perform surface treatment on the second polymer layer to form a number of protrusions on the surface of the second polymer layer;

[0041] Attach the side surfaces with protrusions of the two second polymer layers to the surface of the first polymer layer respectively. Under the action of pressure, make the modified fabric layer and the second polymer layer combine together, and an irregular pore structure is formed between the second polymer layer, adjacent two protrusions and the first polymer layer; after secondary drying, take the composite material as a whole off the substrate to obtain the artificial heart valve composite material.

[0042] Preferably, the modified fabric layer is obtained by dip-coating treatment and drying treatment of the fabric; among them, the fabric is obtained by weaving, knitting or non-woven of fiber materials, and the fiber materials are one or more of polyester, polyethylene, polypropylene, polyamide and polyvinyl chloride. Further, the dip-coating treatment is realized by dip-coating the fabric with the first polymer solution, the mass concentration of the first polymer solution is 0 - 15 w / v%, and the solute is one or more of polyurethane, polycarbonate-polyurethane copolymer, polysiloxane-polyurethane copolymer, styrene / isobutene copolymer, and the solute is one or more of N,N-dimethylformamide, N,N-dimethylacetamide, dimethyl sulfoxide, tetrahydrofuran, dioxane, chloroform, dichloromethane, hexafluoroisopropanol, dioxolane.

[0043] Preferably, the mass concentration of the second polymer solution is 5 - 30 w / v%, and the solute is one or more of polyurethane, polycarbonate-polyurethane copolymer, polysiloxane-polyurethane copolymer, styrene / isobutene copolymer; the solvent of the polymer solution is one or more of N,N-dimethylformamide, N,N-dimethylacetamide, dimethyl sulfoxide, tetrahydrofuran, dioxane, chloroform, dichloromethane, hexafluoroisopropanol, dioxolane.

[0044] Preferably, the coating thickness of the second polymer solution is 100 - 1000 μm; the thickness ratio of the second polymer layer to the modified fabric layer is 1:5 - 5:1.

[0045] Preferably, the protrusions on the surface of the second polymer layer are obtained by intermittently coating a surface treatment liquid on the surface of the second polymer layer, and the coating method is one of spraying, scraping, dipping, spin coating, and roll coating; the surface treatment liquid is an organic solvent or a second polymer solution. It should be noted that since the protrusions formed by the above method are further formed on the surface of the second polymer layer, the thickness at the positions where the protrusions are formed on the second polymer layer becomes larger, but the thickness at other positions where no protrusions are formed remains basically unchanged. Secondly, the protrusions can also be formed by subjecting the second polymer layer to surface treatment by means of heat, light, radiation, etc., causing local melting of the second polymer layer, and forming protrusions on the polymer surface during the melting process.

[0046] When the surface treatment liquid is selected as the second polymer solution, the solute therein can be the same as or different from the solute in the first polymer solution. Preferably, the solutes are the same. At this time, when using the second polymer solution to form protrusions on the second polymer layer, since the solute of the protrusions is the same as that of the first polymer layer, it is beneficial to the stable combination between the protrusions and the first polymer layer, ensuring the stable combination between the second polymer layer and the modified fabric layer, and effectively improving the stability between the various layer structures of the composite material. It should be noted that the protrusions in the present invention can be dot-shaped or continuous linear.

[0047] Preferably, the substrate is a glass plate or other smooth-surfaced plates.

[0048] Preferably, the temperature during the drying process is 40 - 80 °C, and the drying time is 6 - 48 h.

[0049] Preferably, the magnitude of the pressure is 10 - 100 kPa.

[0050] Preferably, the temperature of the secondary drying is 40 - 80 °C, and the time is 2 - 24 h.

[0051] The following further describes an artificial heart valve composite material and its preparation method of the present invention with specific embodiments:

[0052] Example 1

[0053] The polyester woven fabric used in this example was purchased from Suzhou Zhixian Technology Co., Ltd.

[0054] In this example, an artificial heart valve composite material was prepared, and the above composite material includes:

[0055] A modified fabric layer, including a fabric and first polymer layers attached to both sides of the fabric;

[0056] Two polyurethane layers, with a number of protrusions on one side surface of the polyurethane layer and the other side surface being smooth;

[0057] Each polyurethane layer is located on both sides of the modified fabric layer respectively. The side of the polyurethane layer with protrusions is connected to the modified fabric layer, and irregular pore structures are formed between the polyurethane layer, two adjacent protrusions on the polyurethane layer and the modified fabric layer. The pore diameter of the pore structure is 50 - 300 μm, and the surface roughness of the composite material is 80 - 300 nm.

[0058] Furthermore, the preparation method of the above composite material includes the following steps:

[0059] S1. Immerse a polyester woven fabric with a length × width of 200 mm × 60 mm in a tetrahydrofuran solution of polyurethane, then take it out and dry it at 60 °C for 10 min to obtain a modified polyester woven fabric, and the thickness of the modified polyester woven fabric is 50 μm;

[0060] S2. Coat a dimethyl sulfoxide solution of polyurethane with a mass concentration of 10 w / v% on a glass plate, and dry it at 70 °C to obtain a polyurethane layer with a thickness of 10 μm; then, use a doctor blade method to intermittently scrape a N,N - dimethylacetamide solution of polyurethane with a mass concentration of 5 w / v% onto one side surface of the polyurethane layer to form a number of continuous linear protrusions with a thickness of 5 μm on the polyurethane layer surface;

[0061] S3. Attach the modified polyester woven fabric prepared in step S1 to the side surface of the polyurethane layer with protrusions prepared in step S2, so that the protrusions on the polyurethane layer surface are in contact with the modified polyester woven fabric; then, extrude the modified polyester woven fabric under a pressure of 20 kPa. The above protrusions serve as bonding points to stably bond the polyurethane layer and the modified polyester woven fabric together, and then dry it at 60 °C for 12 h to obtain a modified polyester woven fabric with a polyurethane layer attached to one side.

[0062] S4. Repeat step S2;

[0063] S5. Make a polyurethane layer on the other side of the above - mentioned modified polyester woven fabric: Attach the modified polyester woven fabric with a polyurethane layer attached to one side prepared in step S3 to the side surface of the polyurethane layer with protrusions prepared in step S4, so that the protrusions on the polyurethane layer are in contact with the other side of the modified polyester woven fabric; then, extrude the modified polyester woven fabric under a pressure of 20 kPa. The above protrusions serve as bonding points to stably bond the polyurethane layer and the modified polyester woven fabric together, and then dry it at 60 °C for 12 h to finally obtain an artificial heart valve composite material.

[0064] The cross - section SEM image of the composite material prepared in this embodiment is as Figure 1 shown, from Figure 1It can be seen that there are irregular pore structures in the cross-section of the composite material prepared in this embodiment. The existence of the bonding points between the pore structures makes the two combine more closely under a limited contact area, reducing the impact on the softness of the fabric itself after bonding the polyurethane layer and the fabric together, and enabling the composite material to maintain the softness of the fabric itself to the greatest extent. Therefore, when the composite material is used as a valve, it can open and close better; from Figure 2 It can be seen that the surface of the composite material is smooth and flat, which is conducive to blood flow and avoids the appearance of thrombus, showing excellent biocompatibility.

[0065] To explore the stiffness of the composite material prepared in this embodiment, its stiffness was tested under the same conditions as that of untreated blank polyester woven fabric. The specific method of the test principle is as follows: First, the composite material and the fabric were respectively cut into circular pieces with a diameter of 40 mm, and then placed on a paper softness tester to measure the four angles of the circular pieces respectively, and the average value was calculated. The results show that the stiffness values of the composite material and the fabric are close, indicating that the method of treating the fabric according to the present invention can well maintain the softness of the fabric itself. The roughness test method is as follows: The composite material and the fabric were cut into square pieces of 1 cm × 1 cm, fixed on the electron microscope stage through conductive glue, and placed in the electron microscope chamber for microscopic observation; the roughness test field of view was selected, the 3D roughness plug-in was started, and the roughness test was carried out to calculate the average value of Ra. The results show that the surface roughness of the composite material on the side with the coating is significantly lower than that of the fabric, which is conducive to the smooth passage of blood.

[0066] Example 2

[0067] The artificial heart valve composite material prepared in this embodiment was prepared by the following method:

[0068] S1. The polyester woven fabric was impregnated in a dichloromethane solution of polyurethane and then taken out, and then dried at 50 °C for 30 min to obtain a modified polyester woven fabric;

[0069] S2. A solution of polyurethane in N,N-dimethylacetamide with a mass concentration of 25 w / v% was coated on a glass plate and dried at 70 °C to obtain a polyurethane layer with a thickness of 30 μm; then, the surface of one side of the polyurethane layer was treated with a laser to cause partial micro-melting of the surface of the polyurethane layer, and a number of dot-like protrusions with a thickness of 3 μm were formed on the upper surface of the polyurethane layer;

[0070] S3. Attach the modified polyester woven fabric prepared in step S1 to the surface of the polyurethane layer with protrusions prepared in step S2, such that the protrusions on the polyurethane layer are in contact with the modified polyester woven fabric; then, extrude the modified polyester woven fabric under a pressure of 40 kPa to stably bond the polyurethane layer with protrusions and the modified polyester woven fabric together, and then dry at 50 °C for 24 h to obtain a modified polyester woven fabric with a polyurethane layer attached to one side.

[0071] S4. Repeat step S2.

[0072] S5. Attach the modified polyester woven fabric with a polyurethane layer attached to one side prepared in step S3 to the surface of the polyurethane layer with protrusions prepared in step S4, such that the protrusions on the polyurethane layer are in contact with the other side of the modified polyester woven fabric; then, extrude the modified polyester woven fabric under a pressure of 40 kPa to stably bond the polyurethane layer with protrusions and the modified polyester woven fabric together, and then dry at 50 °C for 24 h to attach a polyurethane layer to the other side of the above-mentioned modified polyester woven fabric, thereby obtaining an artificial heart valve composite material.

[0073] Examples 3 to 5

[0074] The differences between Examples 3 to 5 and Example 1 are only that: in steps S2 and S4, the concentration of the polyurethane solution is different from that in Example 1, and the other steps are basically the same as those in Example 1, which will not be elaborated here. The concentration settings of the polyurethane solution in Example 1 and Examples 3 to 5 and the performance of the composite materials prepared under the corresponding conditions are compared in Table 1. It can be seen from the table that the concentration of the second polymer solution has an impact on the performance of the composite material. This is because as the solution concentration increases, the thickness of the prepared polyurethane layer also continuously increases. After being compounded with the fabric, the stiffness of the composite material slightly increases, and at the same time, the smoothness is optimized and the surface roughness continuously decreases.

[0075] Table 1 Comparison of the concentration settings of the polyurethane solution in Example 1 and Examples 3 to 5 and the performance of the composite materials prepared under the corresponding conditions

[0076]

[0077] Examples 6 to 8

[0078] The differences between Examples 6 to 8 and Example 1 are only that: the type of the second polymer solution is different from that in Example 1, and the other steps are all basically the same as those in Example 1, which will not be elaborated here. The type settings of the second polymer solution in Example 1 and Examples 6 to 8 and the performance of the composite materials prepared under the corresponding conditions are compared in Table 2. The results show that the method proposed by the present invention is applicable to further preparing artificial heart valve composite materials with various polymers, and the performance of the prepared composite materials is excellent.

[0079] Table 2 Comparison of the types of the second polymer solution in Example 1 and Examples 6 to 8 and the properties of the composite materials prepared under the corresponding conditions

[0080]

[0081]

[0082] Examples 9 to 12

[0083] The differences between Examples 9 to 12 and Example 1 are only as follows: the coating thickness of the polyurethane solution is different from that in Example 1. The coating thickness settings of the polyurethane solution in Example 1 and Examples 9 to 12 and the performance comparison of the composite materials prepared under the corresponding conditions are shown in Table 3. The results show that when the coating thickness of the polyurethane solution is within the range given in the present invention, the composite materials exhibit excellent properties. This is because: under the appropriate coating thickness, when modifying the woven fabric, the surface roughness of the woven fabric can be improved on the premise of minimizing the influence of the coating process on the properties of the woven fabric itself.

[0084] Table 3 Coating thickness settings of the polyurethane solution in Example 1 and Examples 9 to 12 and performance comparison of the composite materials prepared under the corresponding conditions

[0085]

[0086] Examples 13 to 16

[0087] The differences between Examples 13 to 16 and Example 1 are only as follows: in steps S3 and S5, the pressure magnitude is different from that in Example 1. The pressure magnitude settings in Example 1 and Examples 13 to 16 and the performance comparison of the composite materials prepared under the corresponding conditions are shown in Table 4. The results show that the composite materials prepared within the pressure range given in the present invention exhibit more excellent properties. This is because under the appropriate pressure, the polyurethane layer and the modified fabric layer can be combined together, and irregular pore structures can be formed between them, ensuring that the composite materials can maintain the softness of the fabric and endowing the composite materials with excellent opening and closing properties; while when the pressure is too large, the pore structures are easily compressed, and as the pressure gradually increases, the volume of the pore structures gradually decreases or even disappears, forming a "valley" phenomenon, and the surface roughness increases.

[0088] Table 4 Pressure magnitude settings in Example 1 and Examples 13 to 16 and performance comparison of the composite materials prepared under the corresponding conditions

[0089]

[0090] Comparative Example 1

[0091] The difference between Comparative Example 1 and Example 1 is only that: in steps S2 and S4, after coating the polyurethane / tetrahydrofuran solution on the glass plate, the modified polyester woven fabric is directly attached to the surface of the above solution without surface treatment of the polyurethane layer. Other steps are basically the same as those in Example 1 and will not be repeated here.

[0092] The cross-sectional SEM image of the composite material prepared in Comparative Example 1 is as Figure 3 shown. Comparing Figure 1 and Figure 3 it can be seen that in the composite material prepared in Comparative Example 1, the polyurethane layer and the woven fabric are directly bonded together, and there is no irregular pore structure between the two. In this way, during the process of bonding the polyurethane layer and the woven fabric, since the polyurethane layer completely adheres to the surface of the woven fabric, the polyurethane layer will affect the softness of the woven fabric, thereby affecting the flexibility of the composite material, resulting in the comprehensive performance of the composite material prepared in Comparative Example 1 being inferior to that of Example 1.

[0093] The above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit them. Although the present invention has been described in detail with reference to the preferred embodiments, those of ordinary skill in the art should understand that the technical solutions of the present invention can be modified or equivalently replaced without departing from the spirit and scope of the technical solutions of the present invention.

Claims

1. An artificial heart valve composite material, characterized in that, The composite material includes: A modified fabric layer, including a fabric and a first polymer layer located on both sides of the fabric; A second polymer layer, with a number of protrusions provided on one surface of the second polymer layer, and the other surface of the second polymer layer being smooth; The second polymer layer is located on both sides of the modified fabric layer; One surface of each second polymer layer with the protrusions is located on the surface of the first polymer layer, and an irregular pore structure is formed among the second polymer layer, two adjacent protrusions and the first polymer layer.

2. The composite material for artificial heart valve according to claim 1, wherein the pore size of the pore structure is 50 - 300 μm, and the surface roughness of the composite material is 80 - 300 nm.

3. A method for preparing the artificial heart valve composite material according to claim 1 or 2, characterized in that, It includes the following steps: Immerse the fabric in the first polymer solution to form a first polymer layer on the surface of the fabric, thereby obtaining the modified fabric layer; Coat the second polymer solution on a smooth substrate, and obtain the second polymer layer after drying; Perform surface treatment on the second polymer layer to form a number of protrusions on one surface of the second polymer layer; Attach one surface of each of the two second polymer layers with the protrusions to the surface of the first polymer layer respectively. Under the action of pressure, combine the modified fabric layer with the second polymer layer, and an irregular pore structure is formed among the second polymer layer, two adjacent protrusions and the first polymer layer. After secondary drying, the composite material for artificial heart valve is obtained.

4. The preparation method of the artificial heart valve composite material according to claim 3, wherein, The mass concentration of the second polymer solution is 5 - 30 w / v%; the coating thickness of the second polymer solution is 100 - 1000 μm.

5. The preparation method of the artificial heart valve composite material according to claim 3, characterized in that, The solute of the second polymer solution is one or several of polyurethane, polycarbonate - polyurethane copolymer, polysiloxane - polyurethane copolymer, styrene / isobutene copolymer; the solvent of the second polymer solution is one or several of N,N - dimethylformamide, N,N - dimethylacetamide, dimethyl sulfoxide, tetrahydrofuran, dioxane, chloroform, dichloromethane, hexafluoroisopropanol, dioxolane.

6. The preparation method of the artificial heart valve composite material according to claim 3, characterized in that, The thickness ratio of the second polymer layer to the modified fabric layer is 1:5 - 5:

1.

7. The preparation method of the artificial heart valve composite material according to claim 3, characterized in that, The magnitude of the pressure is 10 - 100 kPa.

8. The preparation method of the artificial heart valve composite material according to claim 3, wherein The protrusions are formed by intermittently coating a surface treatment liquid on the surface of the second polymer layer; the surface treatment liquid is one of an organic solvent or the second polymer solution.

9. The preparation method of the artificial heart valve composite material according to claim 3, wherein, The protrusions are formed by locally melting the second polymer layer by means of heat, light or radiation.

10. The preparation method of the artificial heart valve composite material according to claim 3, characterized in that, The solute of the first polymer solution is one or several of polyurethane, polycarbonate - polyurethane copolymer, polysiloxane - polyurethane copolymer, styrene / isobutene copolymer; the solvent of the first polymer solution is one or several of N,N - dimethylformamide, N,N - dimethylacetamide, dimethyl sulfoxide, tetrahydrofuran, dioxane, chloroform, dichloromethane, hexafluoroisopropanol, dioxolane.

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